Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration Commissioning of State and Local Officials, 72687-72690 [2014-28634]
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Federal Register / Vol. 79, No. 235 / Monday, December 8, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1697]
Privacy Act of 1974; Report of a New
System of Records; Food and Drug
Administration Commissioning of
State and Local Officials
AGENCY:
Food and Drug Administration,
HHS.
Notice of a Privacy Act system
of records.
ACTION:
In accordance with the
requirements of the Privacy Act of 1974
(the Privacy Act) and the Food and Drug
Administration’s (FDA or the Agency)
regulations for the protection of privacy,
FDA is publishing notice of a Privacy
Act system of records entitled, ‘‘FDA
Commissioning of State and Local
Officials, HHS/FDA/ORA’’ System No.
09–10–0022. FDA is deleting the System
of Records Notice (SORN) for ‘‘FDA
Credential Holder File, HHS/FDA/OC’’
System No. 09–10–0003, because the
records covered by that SORN are now
covered by this new SORN and by
existing personnel records SORNs. The
new system of records will contain
information about State and local
officials who have applied for an FDA
commission that would allow them to
assist FDA with its regulatory
compliance and enforcement efforts.
FDA will use the records in this system
to assess qualifications of
commissioning candidates, initiate
background investigations, record the
status of applications, and track the
status of commissioned officials.
DATES: Effective Date: The new system
of records will be effective on December
8, 2014 with the exception of the
routine uses. The routine uses will be
effective on January 22, 2015. Submit
either electronic or written comments
by January 22, 2015.
ADDRESSES: You may submit comments
by any of the following methods:
SUMMARY:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1697 for this notice. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Ryan Cates, Office of Partnerships, Food
and Drug Administration, Element
Building, 12420 Parklawn Dr.,
Rockville, MD 20857, 301–796–5390,
FAX: 301–827–3588, OP–ORA@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on the New System and
the Deleted System
The FDA is establishing a new system
of records referred to as the
Commissioning of State and Local
Officials (COSLO) system, to maintain
records regarding State and local
officials who apply to be commissioned
by FDA. Under section 702(a)(1)(A) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 372(a)(1)(A)),
FDA can commission a health, food, or
drug officer or employee of any State,
territory, or political subdivision thereof
(hereafter State and local officials) to
conduct examinations and
investigations for the purposes of the
FD&C Act.
In addition, FDA is deleting the SORN
entitled ‘‘FDA Credential Holder File,
HHS/FDA/OC’’ (System No. 09–10–
0003). The records covered by that
SORN (credential records for FDA
employees and commissioned officials)
will now be covered by this SORN for
the COSLO system which contains
records pertaining to commissioned
officials, and by other existing
personnel SORNs for records pertaining
to FDA employees.
Issued in Homeland Security
Presidential Directive 12, ‘‘Policy for a
Common Identification Standard for
Federal Employees and Contractors,’’
FDA has completed the process of
issuing Personal Identity Verification
(PIV) badges to current employees and
contractors, and will do the same for all
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new employees and contractors hired in
the future. Records pertaining to those
badges and background investigations
are covered under HHS departmentwide SORN No. 09–90–0777 entitled
‘‘Facility and Resource Access Control
Records System.’’ Any additional
records maintained to identify or
manage FDA personnel designated to
conduct examinations and inspections
under the FD&C Act would be covered
by HHS department-wide SORN No. 09–
90–0018 entitled ‘‘Personnel Records in
Operating Offices’’ or another personnel
SORN.
State and local officials who assist
with FD&C Act examinations and
inspections are issued one or two types
of credentials that differ in scope. All
commissioned individuals receive
Certificates of Commission and are
permitted to receive and review FDA
documents. A subset of commissioned
individuals also receive personal
‘‘pocket credentials’’ identifying them as
FDA commissioned officers and
authorizing them to perform additional
activities such as conducting
inspections, collecting samples, and
verifying records. To obtain pocket
credentials, State and local officials
undergo an Office of Personnel
Management level 5 background
investigation. FDA commission
credentials are different from the PIV
badges issued to FDA employees and
contractors, and are manufactured and
issued by FDA’s Office of Security
Operations, and are not within the
scope of HHS department-wide SORN
No. 09–90–0777.
II. The Privacy Act
The Privacy Act of 1974 (Pub. L. 93–
579) (5 U.S.C. 552a), as amended,
governs the means by which the U.S.
Government collects, maintains, and
uses information about individuals in a
system of records. A ‘‘system of
records’’ is a group of any records under
the control of a Federal Agency from
which information about an individual
is retrieved by the individual’s name or
other personal identifier. The Privacy
Act requires each Agency to publish in
the Federal Register a SORN identifying
and describing each system of records
the Agency maintains, including the
purposes for which the Agency uses
information about individuals in the
system, the routine uses for which the
Agency discloses such information
outside the Agency, and how individual
record subjects can exercise their rights
under the Privacy Act (for example, to
determine if the system contains
information about them).
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A. System Number
nature of the authority granted to a
commissioned individual, the relevant
regulatory program area, the date the
commission was issued, and date of
expiration.
09–10–0022
B. SYSTEM NAME
FDA Commissioning of State and
Local Officials, HHS/FDA/ORA.
G. AUTHORITY FOR MAINTENANCE OF THE SYSTEM
The authorities for maintaining this
system are: Section 702(a) of the FD&C
Act, 44 U.S.C. 3101, and 5 U.S.C. 301.
C. SECURITY CLASSIFICATION
Unclassified.
D. SYSTEM LOCATION
H. PURPOSE(S) OF THE SYSTEM
Records are maintained at several
FDA Headquarters locations and in
component offices of the FDA, in both
Montgomery County, MD and field
locations across the United States.
E. CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM
The records in this system will
contain data collected from the FDA
commissioning applications of
individuals who are State and local
officials who wish to be commissioned
under section 702(a)(1)(A) of the FD&C
Act. This information is gathered for the
purpose of processing and validating
each individual’s qualifications for
commissioning, to initiate the
mandatory background investigation,
and to track the status of commissioned
officials.
Privacy Act notification, access, and
amendment rights relative to the records
maintained in this system are available
only to individuals who are the subject
of records in this system. The
individuals who are the subjects of the
records stored in this system are the
State or local officials who are currently
commissioned, have applied for a
commission, and/or were commissioned
or rejected in the past. Although records
in the system may contain personally
identifiable information related to other
individuals, only the specified
commissioned or commission-seeking
individuals are considered subjects of
records in this system.
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F. CATEGORIES OF RECORDS IN THE SYSTEM
The records in this system will
include: Full name, aliases, date of
birth, home address, work address,
telephone number, work or personal
email address, photograph, educational
history, job title, agency, division, area
of expertise, employment history,
supervisor’s name, signature, and the
outcome of the background
investigation of individuals who apply
for a commission. Should a
commissioned individual with pocket
credentials lose their credentials, he or
she will typically file a police report
and provide a copy of the report to FDA
where it is kept in the individual’s
commissioning file. In addition, the
records in the system will describe the
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Relevant Agency personnel will use
records from this system on a need-toknow basis to:
• Centrally gather data enabling FDA
to determine the suitability, eligibility,
and qualifications of State and local
officials to whom FDA might offer
commissions;
• enable FDA to securely commission
and credential State and local officials
who are particularly qualified to assist
FDA in a special manner for which FDA
credentials are required;
• ensure the safety and security of
FDA facilities, systems, information,
and of facility occupants and users;
• provide appropriate access to FDA
information systems, networks, and
resources;
• enhance FDA’s ability to ensure the
safety of FDA-regulated products
through a secure commissioning
process; and
• centrally gather data on
commissioned officials, thereby
enabling FDA to efficiently maintain the
commissioning program and to support
activities, such as quickly ascertaining
which officials are particularly qualified
to carry out official responsibilities and
providing this information as necessary
to our State and local counterparts.
I. ROUTINE USES OF RECORDS MAINTAINED IN
THE SYSTEM, INCLUDING CATEGORIES OF USERS
AND THE PURPOSES OF SUCH USES
These routine uses specify
circumstances, in addition to those
provided by the Privacy Act at 5 U.S.C.
552a(b), under which records may be
disclosed to recipients outside HHS,
without the individual record subject’s
prior written consent:
• Public disclosures may be made (for
example, on FDA’s Web site) of the
names of commissioned officials, and
other basic information, including the
identification of their State or local
agency, their job titles, the type of
commission, any specific commissioned
areas, and the date of their commission,
to the extent disclosure is not an
unwarranted invasion of personal
privacy.
• Disclosure may be made to
appropriate Federal Agencies and
Department contractors that have a need
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to know the information for the purpose
of assisting the Department’s efforts to
respond to a suspected or confirmed
breach of the security or confidentiality
of information maintained in this
system of records, provided the
information disclosed is relevant and
necessary for that assistance.
• Disclosure may be made to a
Federal, State, local, territorial, tribal,
foreign, or other public authority, on
request, in connection with the hiring or
retention of an employee, the issuance
or retention of a security clearance, the
letting of a contract, or the issuance or
retention of a license, grant, or other
benefit, to the extent that the
information is relevant and necessary to
the requesting Agency’s decision. No
disclosure will be made unless the
information has been determined to be
sufficiently reliable to support a referral
to another office within the Agency or
to another Federal Agency for criminal,
civil, administrative, personnel, or
regulatory action.
• Disclosure of system information
may be made to a State, local, territorial,
and tribal agencies or governments to
provide copies of records that were
originally provided to the Agency by
that entity.
• Disclosure may be made to Federal
Agencies, contractors, and other
individuals or entities who perform
services for the Agency related to this
system of records and who need access
to the records to perform those services.
Recipients shall be required to comply
with the requirements of the Privacy Act
of 1974, as amended, 5 U.S.C. 552a.
• When a record on its face, or in
conjunction with other records,
indicates a violation or potential
violation of law, whether civil, criminal,
or regulatory in nature, disclosure may
be made to the appropriate public
authority, whether Federal, foreign,
State, local, or tribal, or otherwise,
responsible for enforcing, investigating,
or prosecuting such violation, if the
information disclosed is relevant to the
responsibilities of the Agency or public
authority.
• Disclosure may be made to a court
or other tribunal or adjudicative body in
a proceeding, when:
Æ The Agency or any component
thereof; or
Æ any employee of the Agency in his
or her official capacity; or
Æ any employee of the Agency in his
or her individual capacity where the
Department of Justice (DOJ) has agreed
to represent the employee; or
Æ the U.S. Government, is a party to
the proceeding or has an interest in such
proceeding and, by careful review, the
Agency determines that the records are
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both relevant and necessary to the
proceeding and the use of such records
is therefore deemed by the Agency to be
for a purpose that is compatible with the
purpose for which the Agency collected
the records.
• Disclosure may be made to the
National Archives and Records
Administration (NARA) and/or the
General Services Administration for the
purpose of records management
inspections conducted under authority
of 44 U.S.C. 2904 and 2906.
• Disclosure may be made to the DOJ
when:
Æ The Agency or any component
thereof; or
Æ any employee of the Agency in his
or her official capacity; or
Æ any employee of the Agency in his
or her individual capacity where the
Agency or the DOJ has agreed to
represent the employee; or
Æ the U.S. Government, is a party to
litigation or has an interest in such
litigation and, by careful review, the
Agency determines that the records are
both relevant and necessary to the
litigation and the use of such records by
the DOJ is therefore deemed by the
Agency to be for a purpose that is
compatible with the purpose for which
the Agency collected the records.
• In the event HHS/FDA deems it
desirable or necessary, in determining
whether particular records are required
to be disclosed under the Freedom of
Information Act, disclosure may be
made to the DOJ for the purpose of
obtaining its advice.
J. POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM
Records are maintained in hard copy
files, image files, electronic hard drive,
file servers, and other electronic data
storage devices.
2. RETRIEVABILITY
To retrieve information, the system
database is typically queried using any
of the internal data fields. The data
fields encompass any data criterion that
is entered into the system including, but
not limited to, name, FDA region,
credential number (if issued pocket
credentials), certificate expiration date,
State, program area, or authority.
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3. SAFEGUARDS
a. Authorized users. Access is
restricted to FDA employees and
contractors with a Level 5 or higher
clearance who have a need for the
records in the performance of their
duties.
b. Procedural and technical
safeguards. Technical controls include
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K. RETENTION AND DISPOSAL
Commissioning records are
maintained in accordance with FDA’s
Records Control Schedule and the
applicable General Records Schedule
and disposition schedules approved by
NARA. Commissioning records fall
under NARA approved citation N1–
088–09–02 for Commissioning
Documents, the Nationwide List of FDA
Commissions, and Summary Reports of
FDA Commissions. Commissioning
documents are deleted/destroyed 5
years after the end of the fiscal year in
which a commission is revoked or
expires. Records within the nationwide
list of FDA commissions are deleted/
destroyed 5 years after the fiscal year
when they become obsolete or are
superseded. Summary reports of FDA
commissions are deleted/destroyed after
the nationwide list of FDA Commissions
has been updated.
L. SYSTEM MANAGER(S) AND ADDRESS
1. STORAGE
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identification and authentication of the
authorized user, access control, audit
and accountability, system and
communication protection, timely
account disablement/deletion,
configuration management,
maintenance, system and information
integrity, media protection, and incident
response. These controls extend to
remote users as well.
c. Physical safeguards. Physical
safeguards include controlled-access
buildings where all records (such as
diskettes, computer listings, and paper
documents) are maintained in secured
areas, locked buildings, locked rooms,
and locked cabinets.
Ryan Cates, Food and Drug
Administration, Office of Partnerships,
Element Building, 12420 Parklawn Dr.,
Rockville, MD 20857, 301–796–5390,
FAX: 301–827–3588, OP-ORA@
fda.hhs.gov.
M. NOTIFICATION PROCEDURE
In accordance with 21 CFR part 21
Subpart D, an individual may submit a
request to the FDA Privacy Act
Coordinator, with a notarized signature,
to confirm whether records exist about
him or her. Requests should be directed
to the FDA Privacy Act Coordinator,
Division of Freedom of Information,
12420 Parklawn Dr., ELEM–1029,
Rockville, MD 20857. An individual
requesting notification via mail should
certify in his or her request that he or
she is the individual who he or she
claims to be and that he or she
understands that the knowing and
willful request for or acquisition of a
record pertaining to an individual under
false pretenses is a criminal offense
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72689
under the Privacy Act subject to a
$5,000 fine, and indicate on the
envelope and in a prominent manner in
the request letter that he or she is
making a ‘‘Privacy Act Request.’’
Additional details regarding notification
request procedures appear in 21 CFR
part 21, subpart D. A commission holder
may also request an opportunity to
review his or her own file by contacting
the appropriate Regional Food and Drug
Director.
N. RECORD ACCESS PROCEDURES
Procedures are the same as above, in
the Notification Procedure section.
Requesters should also reasonably
specify the record contents being
sought. Some records may be exempt
from access under 5 U.S.C. 552a(d)(5), if
they are ‘‘compiled in reasonable
anticipation of a civil action or
proceeding.’’ If access to requested
records is denied, the requester may
appeal the denial to the FDA
Commissioner. Additional details
regarding record access procedures and
identity verification requirements
appear in 21 CFR part 21, subpart D.
O. CONTESTING RECORD PROCEDURES
In addition to the procedures
described above, requesters should
reasonably identify the record, specify
the information they are contesting,
state the corrective action sought and
the reasons for the correction, and
provide information justifying why the
record is not accurate, complete, timely,
or relevant to an FDA purpose. Rules
and procedures regarding amendment of
Privacy Act records appear in 21 CFR
part 21, subpart E.
P. RECORD SOURCE CATEGORIES
Information in this system is obtained
from the following sources: Directly
from a commissioned individual or
individual under consideration for
commissioning; FDA employee; FDA
contractor; sponsoring State, local or
Federal agency; former sponsoring,
employing or commissioning agency;
other State, local or Federal agencies;
contract employer; and the subject
individual’s former employer.
Q. RECORDS EXEMPTED FROM CERTAIN
PROVISIONS OF THE PRIVACY ACT
None.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
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heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28634 Filed 12–5–14; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2031]
Request for Nominations on the Food
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Food Advisory Committee
for the Center for Food Safety and
Applied Nutrition (CFSAN) notify FDA
in writing. FDA is also requesting
nominations for a nonvoting industry
representative(s) to serve on the Food
Advisory Committee. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current vacancies effective with this
notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
the FDA by January 7, 2015 (see
sections I and II of this document for
further details). Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
January 7, 2015.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Karen
Strambler (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives may
be submitted electronically by accessing
the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
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SUMMARY:
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mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
Karen Strambler, Office of Policy,
Regulations, and Social Science, Center
for Food Safety and Applied Nutrition,
5100 Paint Branch Pkwy., Rm. 1C–016,
College Park, MD 20740, 2400–402–
2589, karen.strambler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
I. CFSAN Advisory Committee, Food
Advisory Committee
The Committee reviews and evaluates
emerging food safety, nutrition and
other food- or cosmetic-related health
issues that FDA considers of primary
importance for its food and cosmetics
programs. The Committee may be
charged with reviewing and evaluating
available data and making
recommendations on matters such as
those relating to: (1) Broad scientific and
technical food- or cosmetic-related
issues; (2) the safety of food ingredients
and new foods; (3) labeling of foods and
cosmetics; (4) nutrient needs and
nutritional adequacy; and (5) safe
exposure limits for food contaminants.
The Committee may also be asked to
provide advice and make
recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
´
´
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
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nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women, and men, members of all racial
and ethnic groups and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: December 1, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–28652 Filed 12–5–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
SUMMARY:
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]]>Agencies
[Federal Register Volume 79, Number 235 (Monday, December 8, 2014)]
[Proposed Rules]
[Pages 72687-72690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28634]
[[Page 72687]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1697]
Privacy Act of 1974; Report of a New System of Records; Food and
Drug Administration Commissioning of State and Local Officials
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of a Privacy Act system of records.
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SUMMARY: In accordance with the requirements of the Privacy Act of 1974
(the Privacy Act) and the Food and Drug Administration's (FDA or the
Agency) regulations for the protection of privacy, FDA is publishing
notice of a Privacy Act system of records entitled, ``FDA Commissioning
of State and Local Officials, HHS/FDA/ORA'' System No. 09-10-0022. FDA
is deleting the System of Records Notice (SORN) for ``FDA Credential
Holder File, HHS/FDA/OC'' System No. 09-10-0003, because the records
covered by that SORN are now covered by this new SORN and by existing
personnel records SORNs. The new system of records will contain
information about State and local officials who have applied for an FDA
commission that would allow them to assist FDA with its regulatory
compliance and enforcement efforts. FDA will use the records in this
system to assess qualifications of commissioning candidates, initiate
background investigations, record the status of applications, and track
the status of commissioned officials.
DATES: Effective Date: The new system of records will be effective on
December 8, 2014 with the exception of the routine uses. The routine
uses will be effective on January 22, 2015. Submit either electronic or
written comments by January 22, 2015.
ADDRESSES: You may submit comments by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1697 for this notice. All comments received may be posted
without change to https://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ryan Cates, Office of Partnerships,
Food and Drug Administration, Element Building, 12420 Parklawn Dr.,
Rockville, MD 20857, 301-796-5390, FAX: 301-827-3588, OP-ORA@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on the New System and the Deleted System
The FDA is establishing a new system of records referred to as the
Commissioning of State and Local Officials (COSLO) system, to maintain
records regarding State and local officials who apply to be
commissioned by FDA. Under section 702(a)(1)(A) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 372(a)(1)(A)), FDA can
commission a health, food, or drug officer or employee of any State,
territory, or political subdivision thereof (hereafter State and local
officials) to conduct examinations and investigations for the purposes
of the FD&C Act.
In addition, FDA is deleting the SORN entitled ``FDA Credential
Holder File, HHS/FDA/OC'' (System No. 09-10-0003). The records covered
by that SORN (credential records for FDA employees and commissioned
officials) will now be covered by this SORN for the COSLO system which
contains records pertaining to commissioned officials, and by other
existing personnel SORNs for records pertaining to FDA employees.
Issued in Homeland Security Presidential Directive 12, ``Policy for
a Common Identification Standard for Federal Employees and
Contractors,'' FDA has completed the process of issuing Personal
Identity Verification (PIV) badges to current employees and
contractors, and will do the same for all new employees and contractors
hired in the future. Records pertaining to those badges and background
investigations are covered under HHS department-wide SORN No. 09-90-
0777 entitled ``Facility and Resource Access Control Records System.''
Any additional records maintained to identify or manage FDA personnel
designated to conduct examinations and inspections under the FD&C Act
would be covered by HHS department-wide SORN No. 09-90-0018 entitled
``Personnel Records in Operating Offices'' or another personnel SORN.
State and local officials who assist with FD&C Act examinations and
inspections are issued one or two types of credentials that differ in
scope. All commissioned individuals receive Certificates of Commission
and are permitted to receive and review FDA documents. A subset of
commissioned individuals also receive personal ``pocket credentials''
identifying them as FDA commissioned officers and authorizing them to
perform additional activities such as conducting inspections,
collecting samples, and verifying records. To obtain pocket
credentials, State and local officials undergo an Office of Personnel
Management level 5 background investigation. FDA commission credentials
are different from the PIV badges issued to FDA employees and
contractors, and are manufactured and issued by FDA's Office of
Security Operations, and are not within the scope of HHS department-
wide SORN No. 09-90-0777.
II. The Privacy Act
The Privacy Act of 1974 (Pub. L. 93-579) (5 U.S.C. 552a), as
amended, governs the means by which the U.S. Government collects,
maintains, and uses information about individuals in a system of
records. A ``system of records'' is a group of any records under the
control of a Federal Agency from which information about an individual
is retrieved by the individual's name or other personal identifier. The
Privacy Act requires each Agency to publish in the Federal Register a
SORN identifying and describing each system of records the Agency
maintains, including the purposes for which the Agency uses information
about individuals in the system, the routine uses for which the Agency
discloses such information outside the Agency, and how individual
record subjects can exercise their rights under the Privacy Act (for
example, to determine if the system contains information about them).
[[Page 72688]]
A. System Number
09-10-0022
B. System Name
FDA Commissioning of State and Local Officials, HHS/FDA/ORA.
C. Security Classification
Unclassified.
D. System Location
Records are maintained at several FDA Headquarters locations and in
component offices of the FDA, in both Montgomery County, MD and field
locations across the United States.
E. Categories of Individuals Covered by the System
The records in this system will contain data collected from the FDA
commissioning applications of individuals who are State and local
officials who wish to be commissioned under section 702(a)(1)(A) of the
FD&C Act. This information is gathered for the purpose of processing
and validating each individual's qualifications for commissioning, to
initiate the mandatory background investigation, and to track the
status of commissioned officials.
Privacy Act notification, access, and amendment rights relative to
the records maintained in this system are available only to individuals
who are the subject of records in this system. The individuals who are
the subjects of the records stored in this system are the State or
local officials who are currently commissioned, have applied for a
commission, and/or were commissioned or rejected in the past. Although
records in the system may contain personally identifiable information
related to other individuals, only the specified commissioned or
commission-seeking individuals are considered subjects of records in
this system.
F. Categories of Records in the System
The records in this system will include: Full name, aliases, date
of birth, home address, work address, telephone number, work or
personal email address, photograph, educational history, job title,
agency, division, area of expertise, employment history, supervisor's
name, signature, and the outcome of the background investigation of
individuals who apply for a commission. Should a commissioned
individual with pocket credentials lose their credentials, he or she
will typically file a police report and provide a copy of the report to
FDA where it is kept in the individual's commissioning file. In
addition, the records in the system will describe the nature of the
authority granted to a commissioned individual, the relevant regulatory
program area, the date the commission was issued, and date of
expiration.
G. Authority for Maintenance of the System
The authorities for maintaining this system are: Section 702(a) of
the FD&C Act, 44 U.S.C. 3101, and 5 U.S.C. 301.
H. Purpose(s) of the System
Relevant Agency personnel will use records from this system on a
need-to-know basis to:
Centrally gather data enabling FDA to determine the
suitability, eligibility, and qualifications of State and local
officials to whom FDA might offer commissions;
enable FDA to securely commission and credential State and
local officials who are particularly qualified to assist FDA in a
special manner for which FDA credentials are required;
ensure the safety and security of FDA facilities, systems,
information, and of facility occupants and users;
provide appropriate access to FDA information systems,
networks, and resources;
enhance FDA's ability to ensure the safety of FDA-
regulated products through a secure commissioning process; and
centrally gather data on commissioned officials, thereby
enabling FDA to efficiently maintain the commissioning program and to
support activities, such as quickly ascertaining which officials are
particularly qualified to carry out official responsibilities and
providing this information as necessary to our State and local
counterparts.
I. Routine Uses of Records Maintained in the System, Including
Categories of Users and the Purposes of Such Uses
These routine uses specify circumstances, in addition to those
provided by the Privacy Act at 5 U.S.C. 552a(b), under which records
may be disclosed to recipients outside HHS, without the individual
record subject's prior written consent:
Public disclosures may be made (for example, on FDA's Web
site) of the names of commissioned officials, and other basic
information, including the identification of their State or local
agency, their job titles, the type of commission, any specific
commissioned areas, and the date of their commission, to the extent
disclosure is not an unwarranted invasion of personal privacy.
Disclosure may be made to appropriate Federal Agencies and
Department contractors that have a need to know the information for the
purpose of assisting the Department's efforts to respond to a suspected
or confirmed breach of the security or confidentiality of information
maintained in this system of records, provided the information
disclosed is relevant and necessary for that assistance.
Disclosure may be made to a Federal, State, local,
territorial, tribal, foreign, or other public authority, on request, in
connection with the hiring or retention of an employee, the issuance or
retention of a security clearance, the letting of a contract, or the
issuance or retention of a license, grant, or other benefit, to the
extent that the information is relevant and necessary to the requesting
Agency's decision. No disclosure will be made unless the information
has been determined to be sufficiently reliable to support a referral
to another office within the Agency or to another Federal Agency for
criminal, civil, administrative, personnel, or regulatory action.
Disclosure of system information may be made to a State,
local, territorial, and tribal agencies or governments to provide
copies of records that were originally provided to the Agency by that
entity.
Disclosure may be made to Federal Agencies, contractors,
and other individuals or entities who perform services for the Agency
related to this system of records and who need access to the records to
perform those services. Recipients shall be required to comply with the
requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a.
When a record on its face, or in conjunction with other
records, indicates a violation or potential violation of law, whether
civil, criminal, or regulatory in nature, disclosure may be made to the
appropriate public authority, whether Federal, foreign, State, local,
or tribal, or otherwise, responsible for enforcing, investigating, or
prosecuting such violation, if the information disclosed is relevant to
the responsibilities of the Agency or public authority.
Disclosure may be made to a court or other tribunal or
adjudicative body in a proceeding, when:
[cir] The Agency or any component thereof; or
[cir] any employee of the Agency in his or her official capacity;
or
[cir] any employee of the Agency in his or her individual capacity
where the Department of Justice (DOJ) has agreed to represent the
employee; or
[cir] the U.S. Government, is a party to the proceeding or has an
interest in such proceeding and, by careful review, the Agency
determines that the records are
[[Page 72689]]
both relevant and necessary to the proceeding and the use of such
records is therefore deemed by the Agency to be for a purpose that is
compatible with the purpose for which the Agency collected the records.
Disclosure may be made to the National Archives and
Records Administration (NARA) and/or the General Services
Administration for the purpose of records management inspections
conducted under authority of 44 U.S.C. 2904 and 2906.
Disclosure may be made to the DOJ when:
[cir] The Agency or any component thereof; or
[cir] any employee of the Agency in his or her official capacity;
or
[cir] any employee of the Agency in his or her individual capacity
where the Agency or the DOJ has agreed to represent the employee; or
[cir] the U.S. Government, is a party to litigation or has an
interest in such litigation and, by careful review, the Agency
determines that the records are both relevant and necessary to the
litigation and the use of such records by the DOJ is therefore deemed
by the Agency to be for a purpose that is compatible with the purpose
for which the Agency collected the records.
In the event HHS/FDA deems it desirable or necessary, in
determining whether particular records are required to be disclosed
under the Freedom of Information Act, disclosure may be made to the DOJ
for the purpose of obtaining its advice.
J. Policies and Practices for Storing, Retrieving, Accessing,
Retaining, and Disposing of Records in the System
1. Storage
Records are maintained in hard copy files, image files, electronic
hard drive, file servers, and other electronic data storage devices.
2. Retrievability
To retrieve information, the system database is typically queried
using any of the internal data fields. The data fields encompass any
data criterion that is entered into the system including, but not
limited to, name, FDA region, credential number (if issued pocket
credentials), certificate expiration date, State, program area, or
authority.
3. Safeguards
a. Authorized users. Access is restricted to FDA employees and
contractors with a Level 5 or higher clearance who have a need for the
records in the performance of their duties.
b. Procedural and technical safeguards. Technical controls include
identification and authentication of the authorized user, access
control, audit and accountability, system and communication protection,
timely account disablement/deletion, configuration management,
maintenance, system and information integrity, media protection, and
incident response. These controls extend to remote users as well.
c. Physical safeguards. Physical safeguards include controlled-
access buildings where all records (such as diskettes, computer
listings, and paper documents) are maintained in secured areas, locked
buildings, locked rooms, and locked cabinets.
K. Retention and Disposal
Commissioning records are maintained in accordance with FDA's
Records Control Schedule and the applicable General Records Schedule
and disposition schedules approved by NARA. Commissioning records fall
under NARA approved citation N1-088-09-02 for Commissioning Documents,
the Nationwide List of FDA Commissions, and Summary Reports of FDA
Commissions. Commissioning documents are deleted/destroyed 5 years
after the end of the fiscal year in which a commission is revoked or
expires. Records within the nationwide list of FDA commissions are
deleted/destroyed 5 years after the fiscal year when they become
obsolete or are superseded. Summary reports of FDA commissions are
deleted/destroyed after the nationwide list of FDA Commissions has been
updated.
L. System Manager(s) and Address
Ryan Cates, Food and Drug Administration, Office of Partnerships,
Element Building, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-
5390, FAX: 301-827-3588, OP-ORA@fda.hhs.gov.
M. Notification Procedure
In accordance with 21 CFR part 21 Subpart D, an individual may
submit a request to the FDA Privacy Act Coordinator, with a notarized
signature, to confirm whether records exist about him or her. Requests
should be directed to the FDA Privacy Act Coordinator, Division of
Freedom of Information, 12420 Parklawn Dr., ELEM-1029, Rockville, MD
20857. An individual requesting notification via mail should certify in
his or her request that he or she is the individual who he or she
claims to be and that he or she understands that the knowing and
willful request for or acquisition of a record pertaining to an
individual under false pretenses is a criminal offense under the
Privacy Act subject to a $5,000 fine, and indicate on the envelope and
in a prominent manner in the request letter that he or she is making a
``Privacy Act Request.'' Additional details regarding notification
request procedures appear in 21 CFR part 21, subpart D. A commission
holder may also request an opportunity to review his or her own file by
contacting the appropriate Regional Food and Drug Director.
N. Record Access Procedures
Procedures are the same as above, in the Notification Procedure
section. Requesters should also reasonably specify the record contents
being sought. Some records may be exempt from access under 5 U.S.C.
552a(d)(5), if they are ``compiled in reasonable anticipation of a
civil action or proceeding.'' If access to requested records is denied,
the requester may appeal the denial to the FDA Commissioner. Additional
details regarding record access procedures and identity verification
requirements appear in 21 CFR part 21, subpart D.
O. Contesting Record Procedures
In addition to the procedures described above, requesters should
reasonably identify the record, specify the information they are
contesting, state the corrective action sought and the reasons for the
correction, and provide information justifying why the record is not
accurate, complete, timely, or relevant to an FDA purpose. Rules and
procedures regarding amendment of Privacy Act records appear in 21 CFR
part 21, subpart E.
P. Record Source Categories
Information in this system is obtained from the following sources:
Directly from a commissioned individual or individual under
consideration for commissioning; FDA employee; FDA contractor;
sponsoring State, local or Federal agency; former sponsoring, employing
or commissioning agency; other State, local or Federal agencies;
contract employer; and the subject individual's former employer.
Q. Records Exempted from Certain Provisions of the Privacy Act
None.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the
[[Page 72690]]
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at https://www.regulations.gov.
Dated: December 1, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28634 Filed 12-5-14; 8:45 am]
BILLING CODE 4164-01-P
